DPOWER Study
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary arteryHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2019/01/016921
- Lead Sponsor
- ational Institute of Pharmaceutical Education and ResearchGuwahati
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion criteria for Type 2 diabetes group
Age > 25 to 65 years
Male and female patients included
HbA1C levels >=7 % to <=10 at visit 1
Total 25 (OH) D levels < 20 ng/ml
Inclusion criteria for Type 2 diabetes with coronary artery diseases (T2DM_CAD)
Age > 25 to 65 years
Male and female patients included
HbA1C levels >=7 % to <=10
Documented acute myocardial infarction, narrowing, or blockage of one or more epicardial coronary artery with greater than 25% stenosis shown in coronary angiography and diagnosed by cardiologists.
Exclusion Criteria for Type 2 diabetes group
SBP/DBP >=140/100 mmHg.
Subjects on Insulin therapy
Prior vitamin D therapy
Subjects with any cardiovascular complications and chronic diseases
Exclusion Criteria for Type 2 diabetes with coronary artery diseases (T2DM_CAD)
Exclusion criteria defined for this study is prior treatment with vitamin D, clinical or laboratory evidence of liver failure, renal failure (plasma creatinine levels > 1.5 mg/dl), Type 1 diabetes, cancer, thyroid disease, and pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glycaemic control <br/ ><br>Cardiac function <br/ ><br>Timepoint: one year <br/ ><br>
- Secondary Outcome Measures
Name Time Method Immune modulation <br/ ><br>Modulation of platelet mediated inflammation <br/ ><br>Timepoint: One year